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Standard and Performance of Medical Titanium and Titanium Alloys at Home and Abroad

Edit: Baoji Jinshan Titanium Industry Co.,Ltd    Date: Feb 28, 2017
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Standard and Performance of Medical Titanium and Titanium Alloys at Home and Abroad


First, the application of titanium in medicine

1, titanium as a new material in China and the world pharmaceutical industry, surgical instruments, human implants and other fields have been used for decades of history, and has achieved great success.

2, the body should be traumatic, tumor-induced bone, joint damage, the use of titanium and titanium can produce artificial joints, bone plate and screws are now widely used in clinical. Also used for hip (including femoral head), knee, elbow, metacarpophalangeal, interphalangeal joint, mandibular, artificial vertebrae (spinal orthosis), pacemaker shell, artificial heart (heart valve) Artificial implant, and titanium mesh in the skull and other aspects of plastic surgery.

3,

The requirements for the implant material can be grouped into three aspects: the biocompatibility of the material with the human body, the corrosion resistance of the material in the human body, and the mechanical properties of the material. The long-term implantation material has the following seven specific requirements:

①, corrosion resistance;

②, biocompatibility;

③, excellent mechanical properties and fatigue performance;

④, toughness;

⑤, low elastic modulus;

⑥, in the combination of good wear resistance;

⑦, satisfying price;

4, surgical implants materials are: metal, polymer, ceramics, metal materials, including stainless steel, cobalt-based alloys and titanium-based alloys.

Comparison of material properties with bone performance and characteristics of implant materials are shown in Table 1 and Table II. It can be seen from Table 2 that stainless steel is inexpensive and easy to process, but corrosion resistance and biocompatibility are not as good as titanium alloy. The wear resistance of cobalt-chromium alloy is better than that of titanium alloy, but the density is too large and too heavy; Alloys are gaining attention due to their high specific strength, good biocompatibility and good corrosion resistance. Titanium alloy is the lack of awareness is poor wear resistance, difficult casting, processing performance is also poor.


Second, domestic and foreign surgical implants with titanium and titanium alloy processing materials standards

1, foreign surgical implants with processing materials standard

Titanium: International Organization for Standardization ISO 5832/2 1999E "Surgical Implants - Pure Titanium Processing Materials"

American Standard: ASTM F67 2006a "Pure Implant for Surgical Implants"

TC4: International Organization for Standardization ISO 5832/3 1996Z "Surgical Implants - Metallic Materials - Ti-6Al-4V Processing Materials"

ASTM F1472 2002 "Ti-6Al-4V Alloy Processing Materials for Surgical Implants"

TC4ELI: ASTM F136 2002a "Specification for Ti-6Al-4VELI (Ultra Low Gap) Processing Materials for Surgical Implants"

TC20: ISO 5832/11 I994 (E) "Surgical Implants - Metallic Materials - Ti-6Al-7Nb Alloy Processing Materials"

ASTM F1295: 2005 "Ti-6Al-7Nb Alloy Processing Materials for Surgical Implants"

2, the Chinese national standard

①, "surgical implants with titanium and titanium alloy processing materials," China's national standard for the GB / T13810-2007, grades are: TA1ELI, TA1, TA2, TA3, TA4, TC4, TC4ELI, TC20.

Varieties are: plate 0.8 ~ 25mm; bar 7.0 ~ 90mm; wire 1.0 ~ 7.0mm;

GB \ T13810-2007 standard in the performance of the performance indicators:

In order to ensure the comprehensive performance (strength, plasticity, toughness, hardness, fatigue resistance and other properties of titanium and titanium alloy) for surgical implants, GB / T13810-2007 standard, High-power microstructure and hydrogen content and other elements of the gap are very strict requirements and control.

③, in order to ensure that titanium and titanium alloy processing materials implanted in the human body safety, service life, the national standard requirements of the plate and bar processing materials for strict 100% ultrasonic testing to ensure that the internal quality of the product.

3, China's national standards and foreign advanced standards comparison

Pure titanium -

①, titanium processing materials in the chemical composition and microstructure and other indicators are equivalent

ISO 5832/2: 1999 (E) requirements;

②, mechanical properties equivalent or higher than ISO 5832/2, and increased the cross-section shrinkage index requirements

③, on the plate and bar to increase the ultrasonic test.

TC4 processing materials -

①, chemical composition and microstructure equivalent to ISO 5832/3: 1996 (E) requirements;

②, mechanical performance requirements higher than ISO 5832/3, an increase of bar section shrinkage index;

③, on the plate and bar to increase the ultrasonic testing requirements

TC4ELI processing materials -

①, in the chemical composition, mechanical properties, bending performance and other indicators are equivalent

ASTM F136 2002a requirements;

②, increased the rating of microstructure;

③, the bar and the plate made of ultrasonic testing requirements;

TC20 alloy processing materials -

①, chemical composition, mechanical properties, microstructure and other indicators are equivalent to

ISO 5832/11 1994 (E) requirements;

②, increased the low-power tissue test;

③, bar increased the ultrasonic test;


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